FDAClass IIOctober 26, 2016

Minor Pack AMS1374(A recall: Sterility Concern

Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in…

Why was Minor Pack AMS1374(A recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers/Expiration Dates: 59360 4/4/2015 60180 7/22/2015 60972 8/20/2015 60716 9/20/2015 61627 10/15/2015 65729 11/15/2015 65371 11/18/2015 62925 11/26/2015 64759 12/26/2015 63807 1/14/2016 64511 1/16/2016 65907 7/11/2016 57777 7/16/2016 67561 8/26/2016 69460 9/11/2016 69554 11/9/2016 72302 1/5/2017 71984 1/27/2017 73801 4/2/2017 74579 4/23/2017 78211 4/26/2017 74831 5/23/2017 74685 5/24/2017 74462 5/25/2017 74578 5/26/2017 75514 7/2/2017 77373 7/19/2017 78511 8/6/2017 75602 9/19/2017 79095 11/4/2017 79588 11/20/2017 79682 1/17/2018 79251 1/26/2018 81260 2/13/2018 80649 2/27/2018

Product
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
1025 kits
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls